Knee OsteoarthritisNCT05110326
Ergon Technique Versus PNF Stretching on Hamstring Flexibility in Knee Osteoarthritis
A study testing ERGON Technique and Proprioceptive Neuromuscular Facilitation (PNF) stretching in people with Knee Osteoarthritis, run by Riphah International University at 1 site in Pakistan.
Trial summary
The study will be a randomized control trial and will be conducted in Pakistan Railway Hospital Rawalpindi. A sample of 60 participants will be taken. Patients will be divided into two groups (A\&B) of 30 participants in each group by sealed envelope method. Read more about this study
- Who is it for?
- Ages 35 to 50 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- ERGON Technique and Proprioceptive Neuromuscular Facilitation (PNF) stretching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Jan 2022to 25 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Unilateral/bilateral osteoarthritis
- Participants with unilateral/bilateral hamstring tightness
- 200 from Active Knee Extension test
- Grade 1 and 2 in Kellgren and Lawrence criteria for knee osteoarthritis
Who cannot join
- Participant failing to fall in the category below will be excluded from the study:
- Any lower extremity injury in past 3 months
- Any fracture or surgery done for pelvis, hip or knee.
- Any neurological symptoms.
- Any recent knee reconstructive surgery
- Burns of lower extremities
- Other musculoskeletal disorders associated with knee joint, Iliotibial band, adductor muscle and Sartorius muscle tightness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Ergon Technique Versus Proprioceptive Neuromuscular Facilitation Stretching on Hamstring Flexibility in Patients With Knee Osteoarthritis
The study will be a randomized control trial and will be conducted in Pakistan Railway Hospital Rawalpindi. A sample of 60 participants will be taken. Patients will be divided into two groups (A\&B) of 30 participants in each group by sealed envelope method. Hot pack will be applied to both groups for 15 minutes at the start of intervention. ERGON Technique(IASTM) will be applied to group A along with strengthening exercise. Proprioceptive Neuromuscular Facilitation (PNF) stretching will be given to group B along with strengthening exercise. A 35 minute session will be given to the patients and 3 sessions will be given once a week. Intervention will be given for 6 weeks. The outcome measure will be Visual analog Scale (VAS), Western Ontario and McMaster Universities Arthritis Index (WOMAC), and Active Knee Extension Test (AKE) will be measured at baseline and at the end of 6th week. Data will be analyzed by SPSS 22.
- Conditions
- Knee Osteoarthritis
- Being tested
- ERGON Technique, Proprioceptive Neuromuscular Facilitation (PNF) stretching
- Keywords
- knee osteoarthritis, Ergon Technique, Proprioceptive Neuromuscular Facilitation stretching, Active Knee Extension Test, Western Ontario and McMaster Universities Arthritis Index, Visual Analogue Scale
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERGON TechniqueOther
- Hot pack for 15 minutes.
- Patient position: Prone with knee flexion approximately 45◦.
- Position of therapist: Standing at the affected side of patient.
- Technique:Massage cream will be applied on the hamstring and overactive or short muscle fibres that are restricted.The instrument will be applied parallel to the muscle fibers, both in a distal to proximal and them proximal to distal direction as needed.Then gentle massage stroking from the origin to the insertion will be performed using the instrument. Instrument Assisted Soft Tissue Mobilization(IASTM) will be applied for 5 minutes.
- Strengthening exercises for quadriceps and hamstring will then be performed.
- Isometrics exercises of Quadriceps: By placing a towel roll below the knee and press and hold for 20 seconds, 5 sets.
- Isometrics exercises Hamstrings: By placing a towel roll below the knee and press and hold for 20 seconds, 5 sets.
- Wall sits: For 10 seconds, 5 sets.
Proprioceptive Neuromuscular Facilitation (PNF) stretchingOther
- The patient will be laid down prone and moist heat will be given for 15 minutes prior to stretching the hamstrings.
- Then patient will be lying supine with hip in 90⁰ of flexion. Patient's knee will be extended until a very mild stretching sensation is felt in hamstring muscles.
- Then patient will be asked to flex the knee against the resistance applied by hand of therapist.
- The patient will be asked to use a force of around 50% of maximal strength and an isometric form of contraction will be gained in the hamstring muscles. The patient will hold the contraction for 8 seconds and then the therapist command to relax the hamstring muscle.
- Immediately after the muscle relaxation the therapist further stretches the hamstring muscles up to a point where the subject reported a mild to moderate stretching sensation without any pain and will be held for 30 seconds.
- The procedure will be repeated 3 times in every session.
Strengthening Exercises:
- Same as ERGON Group
| Study group | Role | What they receive |
|---|---|---|
| ERGON Technique Group | Experimental | Patients in this group will receive ERGON Technique along with conventional therapy Receives: Other: ERGON Technique |
| Proprioceptive Neuromuscular Facilitation(PNF) stretching Group | Experimental | Patients in this group will receive Proprioceptive Neuromuscular Facilitation (PNF) stretching along with conventional therapy Receives: Other: Proprioceptive Neuromuscular Facilitation (PNF) stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain. It is used to find out the intensity of pain.
Measured: 6 Weeks
Western Ontario and McMaster Universities Arthritis Index(WOMAC)
The Western Ontario and McMaster Universities Arthritis Index(WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales.
Measured: 6 Weeks
Active Knee Extension Test
The Active Knee Extension Test is used to assess hamstring muscle length and the range of active knee extension in the position of hip flexion.
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start10 Jan 2022
- Primary completion30 May 2022
- Study completion25 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Waqar Ahmed Awan, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05110326
- Sponsor's protocol ID
- Narmeen Anjum
- Status last verified
- Mar 2023
- First submitted
- 26 Oct 2021
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anjum N, Sheikh RK, Omer A, Anwar K, Khan MMH, Aftab A, Awan WA. Comparison of instrument-assisted soft tissue mobilization and proprioceptive neuromuscular stretching on hamstring flexibility in patients with knee osteoarthritis. PeerJ. 2023 Dec 1;11:e16506. doi: 10.7717/peerj.16506. eCollection 2023.
PubMed 38054019
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ergon Technique Versus Proprioceptive Neuromuscular Facilitation Stretching on Hamstring Flexibility in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05110326
- Acronym / sponsor ID
- Narmeen Anjum
- Conditions
- Knee Osteoarthritis
- Keywords
- knee osteoarthritis, Ergon Technique, Proprioceptive Neuromuscular Facilitation stretching, Active Knee Extension Test, Western Ontario and McMaster Universities Arthritis Index, Visual Analogue Scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 25 Jun 2022 (actual)
- First posted
- 5 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will be a randomized control trial and will be conducted in Pakistan Railway Hospital Rawalpindi. A sample of 60 participants will be taken. Patients will be divided into two groups (A\&B) of 30 participants in each group by sealed envelope method. Hot pack will be applied to both groups for 15 minutes at the start of intervention. ERGON Technique(IASTM) will be applied to group A along with strengthening exercise. Proprioceptive Neuromuscular Facilitation (PNF) stretching will be given to group B along with strengthening exercise. A 35 minute session will be given to the patients and 3 sessions will be given once a week. Intervention will be given for 6 weeks. The outcome measure will be Visual analog Scale (VAS), Western Ontario and McMaster Universities Arthritis Index (WOMAC), and Active Knee Extension Test (AKE) will be measured at baseline and at the end of 6th week. Data will be analyzed by SPSS 22.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERGON Technique Group | Experimental | Other: ERGON TechniquePatients in this group will receive ERGON Technique along with conventional therapy |
| Proprioceptive Neuromuscular Facilitation(PNF) stretching Group | Experimental | Other: Proprioceptive Neuromuscular Facilitation (PNF) stretchingPatients in this group will receive Proprioceptive Neuromuscular Facilitation (PNF) stretching along with conventional therapy |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Unilateral/bilateral osteoarthritis
- Participants with unilateral/bilateral hamstring tightness
- 200 from Active Knee Extension test
- Grade 1 and 2 in Kellgren and Lawrence criteria for knee osteoarthritis
Key exclusion criteria (7 listed)
- Participant failing to fall in the category below will be excluded from the study:
- Any lower extremity injury in past 3 months
- Any fracture or surgery done for pelvis, hip or knee.
- Any neurological symptoms.
- Any recent knee reconstructive surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERGON Technique* Hot pack for 15 minutes. * Patient position: Prone with knee flexion approximately 45◦. * Position of therapist: Standing at the affected side of patient. * Technique:Massage cream will be applied on the hamstring and overactive or short muscle fibres that are restricted.The instrument will be applied parallel to the muscle fibers, both in a distal to proximal and them proximal to distal direction as needed.Then gentle massage stroking from the origin to the insertion will be performed using the instrument. Instrument Assisted Soft Tissue Mobilization(IASTM) will be applied for 5 minutes. * Strengthening exercises for quadriceps and hamstring will then be performed. * Isometrics exercises of Quadriceps: By placing a towel roll below the knee and press and hold for 20 seconds, 5 sets. * Isometrics exercises Hamstrings: By placing a towel roll below the knee and press and hold for 20 seconds, 5 sets. * Wall sits: For 10 seconds, 5 sets. | Other | ERGON Technique Group |
| Proprioceptive Neuromuscular Facilitation (PNF) stretching* The patient will be laid down prone and moist heat will be given for 15 minutes prior to stretching the hamstrings. * Then patient will be lying supine with hip in 90⁰ of flexion. Patient's knee will be extended until a very mild stretching sensation is felt in hamstring muscles. * Then patient will be asked to flex the knee against the resistance applied by hand of therapist. * The patient will be asked to use a force of around 50% of maximal strength and an isometric form of contraction will be gained in the hamstring muscles. The patient will hold the contraction for 8 seconds and then the therapist command to relax the hamstring muscle. * Immediately after the muscle relaxation the therapist further stretches the hamstring muscles up to a point where the subject reported a mild to moderate stretching sensation without any pain and will be held for 30 seconds. * The procedure will be repeated 3 times in every session. Strengthening Exercises: * Same as ERGON Group | Other | Proprioceptive Neuromuscular Facilitation(PNF) stretching Group |
Primary outcome
Visual Analog Scale (VAS)
Time frame: 6 Weeks
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain. It is used to find out the intensity of pain.
Western Ontario and McMaster Universities Arthritis Index(WOMAC)
Time frame: 6 Weeks
The Western Ontario and McMaster Universities Arthritis Index(WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales.
Active Knee Extension Test
Time frame: 6 Weeks
The Active Knee Extension Test is used to assess hamstring muscle length and the range of active knee extension in the position of hip flexion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
- Derived from this study: PubMed 38054019Anjum N, Sheikh RK, Omer A, Anwar K, Khan MMH, Aftab A, Awan WA. Comparison of instrument-assisted soft tissue mobilization and proprioceptive neuromuscular stretching on hamstring flexibility in patients with knee osteoarthritis. PeerJ. 2023 Dec 1;11:e16506. doi: 10.7717/peerj.16506. eCollection 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Waqar Ahmed Awan, PhD principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERGON Technique and Proprioceptive Neuromuscular Facilitation (PNF) stretching in people with Knee Osteoarthritis, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: 6 Weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05110326, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023.